The Sponsor did not have extensive experience in procurement and clinical supply chain management for clinical trials and considered outsourcing of procurement to external parties, as is often done for clinical trials. However, after taking into account the time commitments and budget required for outsourcing, a pragmatic clinical supply chain management approach was adopted. The Sponsor undertook procurement and subsequent supply chain activities internally with a team of pharmacists (one pharmacist for Stage 1 and an additional pharmacist for Stage 2). The experience of managing the trial’s complex supply chain highlighted that it is crucial for the management system to be well resourced with documented and detailed SOPs.
In Stage 1 of the trial, a strategy document – the Pharmacy Plan – was written and distributed to trial sites to serve as a guide for IMP management. Although the Pharmacy Plan provided an overview of what was needed, it did not provide enough detail to meet the complex needs of the trial. As the trial progressed, it was apparent that separate Sponsor and site pharmacy SOPs were needed to document IMP flow from manufacturers to trial participants. Development of these SOPs during Stage 2 ensured standardization of supply chain management across sites.
The SOPs required an appropriate level of detail to ensure a standardized system across the sites, and that resources were in place to ensure the SOPs could be followed. For example, GCP requires temperature monitoring for IMP storage. This was outlined in the Pharmacy Plan and site pharmacists were requested to maintain daily temperature monitoring logs. However, during site monitoring visits conducted by Sponsor pharmacists, challenges with temperature monitoring were identified and highlighted that the guidance in the Pharmacy Plan was not sufficient. At some sites, the temperature was recorded once per day (at noon), but it was recorded twice (at the beginning and at the end of the shift) at other sites. Different thermometers were also used by sites, ranging from simple alcohol filled thermometers to more advanced digital thermometers, and some pharmacies had continuous temperature monitoring systems in place. Thus, data from different sites did not provide a uniform picture or ensure the recommended IMP storage conditions were maintained. To address this gap, Vital Strategies identified calibrated digital thermometers and all site pharmacies were equipped with these thermometers. An SOP on how to use them, and how to monitor and record the temperature was provided to sites. This ensured that temperature monitoring and recording was done consistently across all STREAM site pharmacies.